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axicabtagene ciloleucel (Yescarta)
CAR-T Cell Therapy

How it is administered

Axicabtagene ciloleucel is given as a one-time intravenous (IV) infusion. The treatment is personalized and made from your own T cells, which are collected through a process called leukapheresis. These cells are then genetically modified in a laboratory to target cancer cells and are expanded before being infused back into your bloodstream. The product is supplied as a frozen suspension in a patient-specific infusion bag and is thawed just before administration.

Before receiving axicabtagene ciloleucel, you will receive a short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the infusion. Premedication with acetaminophen and an antihistamine is also recommended to reduce the risk of infusion reactions.

How it works

Axicabtagene ciloleucel is a type of CAR T-cell therapy, which stands for chimeric antigen receptor T-cell therapy. This treatment uses your own immune cells (T cells) that have been genetically modified to recognize and attack cancer cells. Specifically, axicabtagene ciloleucel targets a protein called CD19, which is found on the surface of most B-cell lymphomas, including follicular lymphoma.

After your T cells are collected, they are modified in the lab to express a receptor that binds to CD19. Once these engineered cells are infused back into your body, they seek out and destroy CD19-positive cancer cells. This process can lead to a rapid and powerful immune response against the lymphoma. The therapy is designed to be a one-time treatment, but its effects can last for months or even years, depending on your response.

Common side effects

  • Cytokine release syndrome (CRS) – symptoms include fever, chills, low blood pressure, difficulty breathing, and confusion
  • Neurologic toxicities – such as confusion, headache, tremor, dizziness, difficulty speaking, and, rarely, seizures
  • Fever
  • Fatigue
  • Hypotension (low blood pressure)
  • Encephalopathy (altered mental state)
  • Tachycardia (fast heart rate)
  • Headache
  • Nausea
  • Febrile neutropenia (fever with low white blood cell count)
  • Diarrhea
  • Musculoskeletal pain
  • Infections
  • Chills
  • Decreased appetite

Laboratory abnormalities may include low levels of white blood cells, red blood cells, and platelets, as well as low phosphate and sodium.

Who Should take it

Axicabtagene ciloleucel is indicated for adults with relapsed or refractory follicular lymphoma (FL) who have already received at least two prior lines of systemic therapy. It is also used for certain types of large B-cell lymphoma that have not responded to, or have returned after, other treatments.

This therapy is typically considered when other standard treatments, such as chemotherapy and immunotherapy, have not worked or the lymphoma has come back. Your healthcare team will assess your overall health, previous treatments, and specific type of lymphoma to determine if axicabtagene ciloleucel is appropriate for you.

Who should not take it

There are no absolute contraindications listed for axicabtagene ciloleucel. However, it should not be given to patients with active, serious infections or those who have primary central nervous system lymphoma. Patients with certain health conditions, such as uncontrolled infections, autoimmune diseases requiring systemic immunosuppression, or significant organ dysfunction, may not be suitable candidates for this therapy.

Women who are pregnant should not receive axicabtagene ciloleucel, as its effects on pregnancy are unknown and there is a potential risk of harm to the fetus. The safety and effectiveness of this medication have not been established in children.

Commonly used with

Axicabtagene ciloleucel is typically used as a stand-alone, one-time therapy. However, before the infusion, patients receive a lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine to prepare the body for the CAR T-cell infusion.

Medications such as acetaminophen and antihistamines are given before the infusion to reduce the risk of infusion reactions. Tocilizumab and corticosteroids may be used after the infusion to manage side effects like cytokine release syndrome or neurologic toxicities.

Commonly tested with

In clinical studies, axicabtagene ciloleucel has been tested in combination with lymphodepleting chemotherapy agents such as cyclophosphamide and fludarabine. Supportive medications like tocilizumab (for cytokine release syndrome) and corticosteroids (for severe side effects) are also commonly used in the management of patients receiving this therapy.

No other cancer therapies are typically combined with axicabtagene ciloleucel during its administration, as it is intended to be a single-agent, one-time treatment.

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